Quality Assurance Specialist
About The Position
The Quality Assurance Specialist is responsible for managing and documenting events/discrepancies associated with either product or process, as well as managing/writing any investigations that may result from those events. This role also involves processing and investigating customer/consumer product complaints, preparing annual product reviews, and tracking, trending, and following up on the CAPA program. This position is 100% on-site at the St. Petersburg facility, which is Catalent's primary soft gel development and manufacturing facility in North America, capable of producing 18 billion capsules per year. The specialist interacts directly with manufacturing personnel, overseeing and ensuring compliance with current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs) through periodic inspections and monitoring of process controls in all applicable manufacturing operations, thereby maintaining a high-quality environment within the manufacturing area.
Requirements
- Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology)
- A minimum of three years related experience in QA pharmaceutical manufacturing
- Prior experience working with investigation writing, including root cause analysis and report writing a must
- Working knowledge of cGMPs and/or OSHA regulations required
- Ability to work effectively under pressure to meet deadlines
Nice To Haves
- Prior experience with preparing annual product reviews
Responsibilities
- Managing and documenting events / discrepancies associated with either product or process
- Managing / writing any investigations that may be a result of those events
- Processing and investigating customer / consumer product complaints
- Preparing annual product reviews
- Tracking and trending and follow-up of the CAPA program
- Collaborates with management and supervisory personnel from Operations, Quality Control and Quality Assurance to resolve problems affecting product quality
- Reacting, investigating and following up with Operations for non-conformance issues and working jointly towards resolution
- Provide guidance and plan of action to the manufacturing floor when production events occur as defined by SOP
- Lead investigations of non-compliant issues according to procedures as defined by SOPs
- Prepare complaint investigation reports
- Work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence
- Ensure on time closure of investigations
- May author other types of quality system documents as directed or assigned by QA management
- Liaise with customers to ensure customer requirements are satisfied
- Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking, trending, and closure
- Ensure on time closure of annual product reports
- Other duties as assigned
Benefits
- Competitive medical benefits
- 401K
- 152 hours of PTO
- 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
- Rewarding opportunities to further your career
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
